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510(k) K161548

Osseointegrated Fixtures by Southern Implants (Pty), Ltd. — Product Code FZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2016
Date Received
June 3, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
Review Panel
SU
Submission Type

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